The project objective is to provide a topical dermatologic formulation for the treatment and management of pseudofolliculitis barbae (PFB). PFB can affect anyone who shaves, but is particularly prevalent in the African-American and Hispanic populations. Although men and women may suffer with PFB, it is especially an issue for men with coarse and/or curly facial hair. Based on US Census Data and a review of medical literature regarding PFB rates, approximately 17% of the US population may be affected. Problems of primary interest that are associated with PFB are those encountered by people required to use gas masks or devices requiring a good seal of a self-contained breathing apparatus (SCBA) to the facial area. Compliance issues are extremely important for members of uniformed services (e.g., policemen and firemen), military and healthcare professionals, and other hazardous material personnel. ISW Group has developed a proprietary and patented topical formulation that is effective in the treatment and management of PFB. This project aims to develop this formulation through the pre-IND and IND submission to the FDA. ISW will execute pre-clinical safety and toxicology studies and formulation development required for clinical trials.